MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. OES BRONCHOFIBERSCOPE

Model Number	BF-P60
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device was not returned to omsc for evaluation.The exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available, this report will be supplemented.
Event or Problem Description
Olympus medical systems corp.(omsc) was informed that during the incoming inspection for repair the at service department of olympus (b)(4), it was found the instrument channel port of the subject device had been loosened, deformed, scratched, rattled, or detached.There was no report of patient injury associated with this event.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the device evaluation result and correct in the initial report submitted on january 3, 2021.The subject device has not been returned to olympus medical systems corp.(omsc) for evaluation.Olympus europa se & co.Kg (oekg) checked the subject device and found that there was no failure of the instrument channel port, the failure of the instrument channel port as already reported had not occurred actually.Therefore omsc concluded that there was no reportable event in this event, there was no need to submit the report.

• Brand Name: OES BRONCHOFIBERSCOPE
• Common Device Name: BRONCHOFIBERSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 11105195
• Report Number: 8010047-2021-00796
• Device Sequence Number: 19011393
• Product Code: EOQ
• UDI-Device Identifier: 04953170308123
• UDI-Public: 04953170308123
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K023984
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: BF-P60
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/09/2020
• Supplement Date Received by Manufacturer: 01/28/2021
• Initial Report FDA Received Date: 01/03/2021
• Supplement Report FDA Received Date: 02/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1